Male sexual impotence treatment apparatus

ABSTRACT

A male sexual impotence treatment apparatus comprises an adjustable restriction device ( 234 ) implanted in an impotent patient and engaging the corpora cavernosa or crura or the prolongation thereof ( 244 ). An implanted adjustment device is adapted to adjust the restriction device to temporarily contract the corpora cavernosa, in order to restrict the blood flow leaving the penis when the patient desires to achieve erection. An implanted powered hydraulic operation device ( 246 ) operates the adjustment device.

This application is the U.S. National Phase of International ApplicationNo. PCT/SE01/00305, filed Feb. 14, 2001, which designated the U.S., andwhich claims the benefit of Provisional Application Ser. No. 60/182,221,filed Feb. 14, 2000.

The present invention relates to a male sexual impotence treatmentapparatus comprising an adjustable restriction device implantable in amale impotent patient for engaging the corpora cavernosa or crura or theprolongations thereof of the patient's penile tissue. An implantableadjustment device is provided for adjusting the restriction device totemporarily contract the corpora cavernosa or crura or the prolongationsthereof to restrict the blood flow leaving the penis, and an implantableoperation device is provided for operating the adjustment device.

Male sexual impotence is a widespread problem. Many different solutionsto this problem have been tried. A main solution currently practised anddisclosed in for instance U.S. Pat. Nos. 5,437,605 and 4,841,461 is toimplant a hydraulic inflatable/contractable silicon prosthesis in thecavities of the corpora cavernosa of the patient's penis. In fluidconnection with this prosthesis is a reservoir implanted in the scrotum.By manual pumping action the prosthesis is filled with fluid from thereservoir to effect errect penile condition or is emptied of fluid,which returns to the reservoir, to effect flaccid penile condition.However, there are several more or less severe disadvantages of thismain solution. Above all, the penis is more or less damaged by theoperation and it is practically impossible to reverse the operation.Another disadvantage is that rather strong forces act against thisimplanted prosthesis resulting in a significant risk of the prosthesisbeing broken.

Another solution to achieve erection is to restrict the blood flowleaving the penis. For example, U.S. Pat. No. 4,829,990 discloses twohydraulically operated inflatable cuffs wrapped around the respectivecrura. A disadvantage of such a solution is that it involves complicatedsurgery. Another example on this solution is U.S. Pat. No. 4,828,544,which discloses an artificial fistula system surgically implanted andproviding a primary fistula between the femoral artery and the femoralvein and a secondary fistula for leading blood from the the primaryfistula to the penis. An inflatable balloon engages the primary fistulabetween the secondary fistula and the vein. The balloon is in fluidconnection with a manually compressible reservoir implanted in thescrotum. Again, implantation of this artifical fistula system requiresdelicate surgery.

Yet another solution is to inject a substance in the penile vein systemto achieve erection. However, injections are painful and complicated forthe patient.

The object of the present invention is to provide a simple male sexualimpotence treatment apparatus, which requires relatively uncomplicatedsurgery.

This objekt is obtained by an apparatus of the kind described initiallycharacterised in that the operation device comprises a powered operationdevice.

With the expression “the prolongations thereof” should be understood thepenile tissue extending from the crura inside the human body andfollowing the pathway of the blood flow leaving the penis, i.e. wherethe penile exit veins extend.

Generally, the restriction device is adapted to contract the corporacavernosa or crura or the prolongations thereof as a single unit, whichrequires relatively simple surgery. Alternatively, however, therestriction device may comprise two restriction members adapted tocontract the respective corpora cavernosa or crura or the prolongationsthereof.

The restriction device may control the contraction of the corporacavernosa or crura or the prolongations thereof, preferably to changesteplessly. Suitably, the adjustment device adjusts the restrictiondevice such that the restriction device provides a predeterminedcontraction of the corpora cavernosa or crura or the prolongationsthereof that is satisfactory for the patient. A satisfactory contractionis achieved when the differential pressure between the arterial andvenous penile blood pressures has increased enough to cause erection ofthe patient's penis while blood still is flowing through the penis.

The adjustment device preferably adjusts the restriction device in anon-invasive manner.

The adjustment device may adjust the restriction device in anon-magnetic manner, i.e. magnetic forces may not be involved whenadjusting the restriction device. Also, the adjustment device may adjustthe restriction device in a non-thermal manner, i.e. thermal energy maynot be involved when adjusting the restriction device.

The expression “powered” should be understood as energised witheverything without manual force, preferably electric energy. In otherwords, the adjustment device is operated in a non-manual manner. Theexpression “non-manual manner” should be understood to mean that theadjustment device is not operated by manually touching subcutaneouslyimplanted components of the apparatus or not manipulated by touching theskin of the patient. Thus, as opposed to prior practice when treatingmale sexual impotence, the adjustment device of the invention is notoperated by manual forces, such as by manually compressing a fluidcontaining balloon implanted in the scrotum or in the region of labiamajora. Of course, manual manipulation of a subcutaneous start button orthe like for activating the powered operation device is permitted withinthe scope of the present invention.

Alternatively, or in combination with a powered operation device, theservo means may be used, which enables manual manipulation without needfor strong manipulation forces. The servo means may comprise hydraulicmeans, electric control means, magnetic means, or mechanical means,which may be activated by manual manipulating means. Using a servosystem will save the use of force when adjusting the adjustment device,which may be of importance in many applications.

The term “servo means” encompasses the normal definition of a servomechanism, i.e. an automatic device that controls large amounts of powerby means of very small amounts of power, but may alternatively oradditionally encompass the definition of a mechanism that transfers aweak force acting on a moving element having a long stroke into a strongforce acting on another moving element having a short stroke. The servomeans may comprise a motor, preferably an electric motor, which may bereversible.

In accordance with a main embodiment of the invention, the apparatuscomprises a reservoir, preferably containing a predetermined amount ofhydraulic fluid, also implantable in the patient, wherein the operationdevice, suitably electrically powered, operates the adjustment device byusing the hydraulic fluid of the reservoir.

The adjustment device may comprise an expandable cavity in therestriction device, wherein the corpus cavernosum or crura or theprolongation thereof is sqeezed upon expansion of the cavity andreleased upon contraction of the cavity. In this embodiment theoperation device is adapted to distribute hydraulic fluid from thereservoir to expand the cavity, and from the cavity to the reservoir tocontract the cavity.

A fluid distribution tube may readily be connected between the reservoirand the cavity in a manner so that the tube does not interfere withother implanted components of the apparatus.

Preferably, the reservoir defines a chamber for the predetermined amountof fluid and the operation device changes the volume of the chamber. Theoperation device suitably comprises first and second wall portions ofthe reservoir and is adapted to provide relative displacement betweenthe first and second wall portions of the reservoir, in order to changethe volume of the chamber.

The operation device may be adapted to provide said relativedisplacement in response to the pressure in the reservoir. Suitably, theoperation device comprises a pressure controlled hydraulic operationdevice. For safety, an alarm may be provided for generating an alarmsignal in response to the lapse of a predetermined time period duringwhich the pressure controlling the hydraulic operation device exceeds apredetermined high value.

Suitably, the operation device is adapted to distribute fluid from thereservoir to the cavity of the restriction member in response to apredetermined first displacement of the first wall portion of thereservoir relative to the second wall portion of the reservoir and maydistribute fluid from the cavity to the reservoir in response to apredetermined second displacement of the first wall portion relative tothe second wall portion.

The first and second wall portions of the reservoir may be displaceablerelative to each other by a magnetic, hydraulic, or electric powermeans, such as an electric motor. In this embodiment no pump is used,only the volume of the reservoir is varied. This is of great advantagecompared to the solution described below when the operation devicecomprises a pump used to pump fluid between the reservoir and theadjustment device because there is no need for a non-return valve and itis still possible to have fluid going both to and from the reservoir.Thus, the significant risk of malfunction when using such a non-returnvalve implanted in the patient is eliminated.

The operation device may comprise hydraulic means and a fluid conduitextending between the hydraulic means and the adjustment device. Thehydraulic means and conduit are devoid of any non-return valve. Thereservoir may form part of the conduit and a fluid chamber with avariable volume. The operation device may distribute fluid from thefluid chamber to the adjustment device by reduction of the volume of thechamber and withdraw fluid from the adjustment device by expansion ofthe volume of the chamber. The operation device preferably comprises amotor for moving a movable wall of the reservoir for changing the volumeof the chamber. Any kind of motor could be used for the differentoperations as well as wireless remote solutions for controlling theoperations.

The restriction device preferably is operable to perform a reversiblefunction and accordingly there is a reversing device implantable in thepatient for reversing the function performed by the restriction device.Such a reversing function preferably involves enlarging and restrictingthe blood flow passageway by the restriction device, suitably in astepless manner. In this connection, the control device suitablycontrols the reversing device, which may include a switch, to reversethe function performed by the restriction device. The reversing devicemay comprise hydraulic means including a valve for shifting the flowdirection of a fluid in the hydraulic means. Alternatively, thereversing device may comprise a mechanical reversing device, such as aswitch or a gearbox.

Where the reversing device comprises a switch the control devicesuitably controls the operation of the switch by shifting polarity ofreleased energy supplied to the switch. The switch may comprise anelectric switch and the source of energy may supply electric energy forthe operation of the switch. The switch mentioned above may comprise anelectronic switch or, where applicable, a mechanical switch.

Where the operation device comprises a motor, the reversing device isadapted to reverse the motor.

In accordance with another particular embodiment of the invention, theoperation device comprises a pump for pumping fluid between thereservoir and the adjustment device. A mechanical solution is proposedin which it is possible to pump fluid from the reservoir to theadjustment device and vice versa just by pushing an activation member inone direction. The pump preferably comprises a first activation memberfor activating the pump to pump fluid from the reservoir to theadjustment device, and a second activation member for activating thepump to pump fluid from the adjustment device to the reservoir. At leastone of the first and second activation members may be operable by manualmanipulation, preferably to permit manual pushing, pulling or rotationthereof in one direction, or by a device powered magnetically,hydraulically, or electrically (e.g. by an electric motor), or beoperable by a combination of these methods. Suitably, at least one ofthe activation members may be adapted to operate when subjected to anexternal pressure exceeding a predtermined magnitude.

Another alternative is a pump pumping in only one direction and anadjustable valve to change the direction of fluid to either increase ordecrease the amount of fluid in the reservoir. This valve may bemanipulated either manually, mechanically, magnetically, orhydraulically.

The main embodiment of the invention described above including thereservoir may alternatively be equipped with a servo means comprising areverse servo. The term “reverse servo” is to be understood as amechanism that transfers a strong force acting on a moving elementhaving a short stroke into a weak force acting on another moving elementhaving a long stroke; i.e. the reverse function of the above-definedalternative mechanism of a normal servo mechanism. A first closedhydraulic system that controls another closed hydraulic system in whichhydraulic means of the adjustment device is incorporated may be used.Minor changes in the amount of fluid in a smaller reservoir of the firstsystem could then be transferred by the reverse servo into major changesin the amount of fluid in a larger reservoir in the second system. Inconsequence, the change of volume in the larger reservoir of the secondsystem affects the hydraulic means of the adjustment device. Forexample, a short stroke that decreases the volume of the smallerreservoir will cause the larger reservoir to supply the adjustmentdevice with a large amount of hydraulic fluid, which in turn results ina long mechanical adjustment stroke on the restriction device.

The great advantage of using such a reverse servo is that the largervolume system could be placed inside the abdomen or retroperitoneumwhere there is more space and still it would be possible to use manualmanipulation means of the smaller system subcutaneously. The smallerreservoir could be controlled directly or indirectly by a fluid supplymeans. The fluid supply means may include another small reservoir, whichmay be placed subcutaneously and may be activated by manual manipulationmeans. Both the normal servo means and the specific reverse servo may beused in connection with all of the various components and solutionsdescribed in the present specification.

Thus, the reverse servo may be adapted to provide relative displacementbetween the first and second wall portions of the reservoir, suitably inresponse to the pressure in the reservoir, in order to change the volumeof the chamber of the reservoir.

Generally, the servo means, including the reverse servo, comprises apressure controlled servo means. The alarm mentioned above mayalternatively be adapted to generate an alarm signal in response to thelapse of a predetermined time period during which the pressurecontrolling the servo means exceeds a predetermined high value.

The reverse servo may comprise magnetic means, electric means or manualmanipulation means or a combination thereof. Preferably, however, thereverse servo comprises hydraulic means.

In accordance with a particular embodiment of the invention, the reverseservo further comprises a servo reservoir defining a chamber containingservo fluid, and the operation device comprise first and second wallportions of the servo reservoir, which are displaceable relative to eachother to change the volume of the chamber of the servo reservoir. Thefirst and second wall portions of the servo reservoir may bedisplaceable relative to each other by magnetic means, hydraulic means,or electric control means.

Where the reverse servo comprises hydraulic means it may furthercomprise a fluid supply reservoir connected to the servo reservoir in aclosed system and containing a further predetermined amount of fluid.The fluid supply reservoir defines a chamber for the furtherpredetermined amount of fluid and the operation device is adapted tochange the volume of the chamber and thereby control the amount of fluidin the servo reservoir. The fluid supply reservoir comprises first andsecond wall portions, which are displaceable relative to each other tochange the volume of the chamber of the fluid supply reservoir.Suitably, the fluid supply reservoir increases the amount of fluid inthe servo reservoir in response to a predetermined first displacement ofthe first wall portion of the fluid supply reservoir relative to thesecond wall portion of the fluid supply reservoir and decreases theamount of fluid in the servo reservoir in response to a predeterminedsecond displacement of the first wall portion of the fluid supplyreservoir relative to the second wall portion of the fluid supplyreservoir.

In accordance with an embodiment of the invention, the adjustment devicecomprises a hydraulic adjustment device, and an implantable reservoircontaining a predetermined amount of hydraulic fluid and a conduitproviding fluid connection between the reservoir and the hydraulicadjustment device are provided. The operation device is adapted tooperate the hydraulic adjustment device by distributing hydraulic fluidthrough the conduit between the reservoir and the hydraulic adjustmentdevice, wherein the conduit and hydraulic adjustment device are devoidof any non-return valve to permit free flow of hydraulic fluid in bothdirections in the conduit. Preferably, the reservoir forms a fluidchamber with a variable volume, and the operation device is adapted todistribute fluid from the chamber to the adjustment device by reductionof the volume of the chamber and to withdraw fluid from the adjustmentdevice by expansion of the volume of the chamber. The operation devicemay comprise a motor or a pump. Alternatively, the operation device maycomprise a movable wall of the reservoir for changing the volume of thechamber. For example, the operation device may be adapted to change thevolume of the chamber by moving the movable wall in response to thepressure in the chamber.

In the above embodiments including a reservoir for hydraulic fluid aninjection port may be provided for subcutaneous implantation in thepatient to be in fluid communication with the chamber of the reservoir.The injection port may be integrated in the reservoir. Such an injectionport may be provided for enabling, normally single, once-and-for-all,calibration of the amount of fluid in the hydraulic system used.

In the various embodiments hereinafter described the restriction devicegenerally forms an at least substantially closed loop. However, therestriction device may take a variety of different shapes, such as theshape of a square, rectangle or ellipse. The substantially closed loopcould for example be totally flat, i.e. thin as seen in the radialdirection. The shape of restriction device may also be changed duringuse, by rotation or movements of the restriction device in anydirection. A physical lumen, such as the corpora cavernosa or crura,often is easier to contract by moving two opposite sidewalls of thelumen against each other. Thus, the restriction device may be designedto perform such a contracting effect of the opposite walls of thecorpora cavernosa or crura or the prolongations thereof, oralternatively the opposite walls of each one of the corpora cavernosa orcrura or the prolongations thereof. Either mechanical or hydraulicsolutions may be employed to operate the restriction device.Alternatively, the restriction device may comprise an adjustable cuff, aclamp or a roller for bending or rotating the corpora cavernosa or cruraor the prolongations thereof to contract them. The bending or rotatingmembers may take any shape and be either hydraulic or non-inflatable.

Preferably the restriction device comprises an elongated restrictionmember and forming means for forming the restriction member into atleast a substantially closed loop around the corpora cavernosa or cruraor the prolongations thereof, wherein the loop defines a restrictionopening, whereby the adjustment device adjusts the restriction member inthe loop to restrict the blood flow leaving the penis.

Advantageously, the forming means may form the restriction member into aloop having a predetermined size. Alternatively, the forming means mayform the restriction member into a loop selected from severalpredetermined sizes.

The adjustment device may change the size of the restriction openingsuch that the outer circumferential confinement surface of therestriction member either is changed or is unchanged.

The elongated restriction member may be flexible, for example take theshape of a belt or cord, and the adjustment device may pull a firstportion of the flexible restriction member from a second portion of theflexible restriction member opposite the first portion in the loop tosqueeze the corpora cavernosa or crura or the prolongations thereofbetween the opposite lengths of the elongated flexible restrictionmember to restrict the blood flow leaving the penis. The restrictionmember may be non-inflatable, and the adjustment device may mechanicallyadjust the restriction member in the loop.

Preferably the adjustment device is operable to adjust the restrictiondevice to steplessly change the contraction of the corpora cavernosa orcrura or the prolongations thereof.

The adjustment device may mechanically or hydraulically adjust therestriction device. In the embodiments described the adjustment devicemay either mechanically or hydraulically adjust the restriction device,where applicable. It should be noted that the operation device mightmechanically or hydraulically operate the adjustment deviceirrespectively of whether the adjustment device is adapted to adjust therestriction device mechanically or hydraulically.

In accordance with an embodiment of the invention, the restrictiondevice comprises at least two elements on opposite or different sides ofthe corpus cavernosum or crura or the prolongation thereof, and theadjustment device decreases the distance between the elements to squeezethe corpus cavernosum or crura or the prolongation thereof between theelements, thereby restricting the blood flow passageway. It is alsopossible to use only one element and squeeze the corpus cavernosum orcrura or the prolongation thereof against human bone or tissue. Theelements above may as well as all the restriction members mentioned inthis application be everything from rigid to soft.

In accordance with an alternative, the restriction device bends orrotates a portion of the corpus cavernosum or crura or the prolongationthereof to restrict the blood flow passageway in the same. For example,the restriction device may comprise at least two bending members, suchas cylindrical or hour-glass shaped rollers, positioned on opposite ordifferent sides of the corpus cavernosum or crura or the prolongationthereof and displaced relative to each other along the corpus cavernosumor crura or the prolongation thereof, and the adjustment device may movethe bending members against the corpus cavernosum or crura or theprolongation thereof to bend the latter to restrict the blood flowpassageway. The restriction device may also rotate a portion of thecorpus cavernosum or crura or the prolongation thereof. The bending orrotating members may take any shape and be either hydraulic ornon-inflatable.

Alternatively, the two bending members one placed more distal than theother may be rotated in opposite directions relative to each other. Withinterconnecting means for example flexible bands between the bendingmembers a restriction will occur between the bending members when theyare rotated.

Preferably the adjustment device is operable to adjust the restrictiondevice to steplessly change the restriction of the blood flow passagewayin the corpus cavernosum or crura or the prolongation thereof.

All embodiments according to the invention may be controlled by awireless remote control.

In accordance with an advantageous embodiment of the invention, there isprovided a wireless remote control for non-invasively controlling theoperation device. The remote control may conveniently comprise anexternal hand-held remote control unit, which is manually operable bythe patient to control the restriction device to squeeze and release thecorpus cavernosum or crura or the prolongation thereof. With thewireless remote control the apparatus of the invention is convenientlycontrolled by the patient when he so desires, which is of greatadvantage compared to the prior art procedures. With the remote controlthe apparatus of the invention is conveniently controlled to adjust theimplanted restriction device to release the blood flow passageway whenthe patient wants to relieve himself or herself.

The remote control may advantageously be capable of obtaininginformation related to important parameters, such as the condition ofthe blood flow passageway or the pressure against the restrictiondevice, and of commanding the operation device to operate the adjustmentdevice to adjust the restriction device in response to obtainedinformation. With the remote control the apparatus of the invention isconveniently controlled to adjust the implanted restriction device toopen and close the blood flow passageway. The adjustment device maycontrol the restriction device to steplessly change the restriction ofthe passageway.

Preferably, the wireless remote control comprises a separate signaltransmitter or receiver and a signal receiver or transmitter implantedin the patient. For example, the signal transmitter and signal receivermay transmit and receive a signal in the form of digital pulses, whichmay comprise a magnetic or electric field. Alternatively, which ispreferred, the signal transmitter and signal receiver may transmit andreceive an electromagnetic wave signal, a sound wave signal or a carrierwave signal for a remote control signal. The receiver may comprise animplanted control unit for controlling the adjustment device in responseto a control signal from the signal transmitter. Any known orconventional signal transmitting or signal receiving means that issuitable for use with a human or mammal patient may be provided as thesignal transmitter or signal receiver.

The apparatus of the invention may further comprise an implantedenergiser unit for providing energy to energy consuming implantedcomponents of the apparatus, such as electronic circuits and/or a motorfor operating the adjustment device. Where a motor is provided thecontrol unit is adapted to power the motor with energy provided by theenergiser unit in response to a control signal received from the signaltransmitter. The motor may be any type of motor, such as a pneumatic,hydraulic or electric motor and the energiser unit may power the motorwith pressurized gas or liquid, or electric energy, depending on thetype of motor. Where the motor is an electric motor, it may powerpneumatic or hydraulic equipment.

The remote control advantageously comprises wireless energy transferdevice for transferring energy from outside the patient's body to energyconsuming implantable components of the apparatus. The energy transferdevice may comprise said energiser unit is adapted to transform energyfrom the control signal, as it is transmitted to the signal receiver,into electric energy. Where the operation device comprises a motor thewireless energy transfer device is adapted to directly power the motorwith transferred energy.

The energy transferred by the wireless energy transfer device preferablycomprises a signal, suitably a wave signal. The energy transferred bythe wireless energy transfer device may comprise an electric field or amagnetic field or a combination thereof. The signal may be analog ordigital or a combination thereof. The energy transfer device maytransfer the energy from the signal into a direct, pulsating direct oralternating current or a combination thereof.

Any of the above mentioned signals may comprise analog or digitalpulses. The analog or digital signal may comprise a magnetic field or anelectric field or a combination thereof. Where the signal is a wavesignal it may comprise an electromagnetic wave signal, a sound wavesignal or a carrier wave signal for a remote control signal or acombination thereof. Where a carrier signal is used it may be frequency,amplitude or frequency and amplitude modulated.

The apparatus of the invention may comprise an implantable source ofenergy for powering the operation device and/or for energizing otherenergy consuming components of the apparatus, wherein the energy fromthe source of energy is releasable from outside the patient's body.Furthermore, the apparatus may comprise an energy transmission devicefor wireless transmission of energy of a first form and an energytransforming device implantable in the patient for transforming theenergy of the first form into energy of a second form, to be supplied tothe source of energy and/or other implantable energy consuming parts ofthe apparatus. The energy transforming device may transform the wirelessenergy directly or indirectly into energy different than the wirelessenergy for operation of the restriction device. Typically, the energy ofthe second form is different than the energy of the first form. Thefunction of the energy transmission device may be different from that ofthe energy transforming device.

An implantable motor or pump for operating the adjustment device may beprovided, wherein the energy transmission device may be adapted totransmit wireless energy in the form of a magnetic field orelectromagnetic waves or field for direct power of the motor or pump, asthe wireless energy is being transmitted. Suitably, the energytransmission device transmits energy by at least one signal separatefrom the above mentioned control signal.

An implantable stabiliser for stabilising the energy of the first orsecond form may be provided. Where the energy of the second formcomprises electric current, the stabiliser suitably comprises at leastone capacitor.

Generally, the source of energy comprises a battery, accumulator,capacitor or a combination thereof.

In accordance with an embodiment of the invention, the apparatuscomprises a control device adapted to produce wireless energy fordirectly powering the operation device and/or for energizing otherenergy consuming components of the apparatus.

Generally, the wireless energy may comprise a wave signal including asound wave signal, an ultrasound wave signal, an electromagnetic wavesignal, an infrared light signal, a visible light signal, an ultraviolet light signal, a laser light signal, a micro wave signal, a radiowave signal, an x-ray radiation signal or a gamma radiation signal.

Any of the above mentioned signals may comprise a wave signal includinga sound wave signal, an ultrasound wave signal, an electromagnetic wavesignal, an infrared light signal, a visible light signal, an ultraviolet light signal, a laser light signal, a micro wave signal, a radiowave signal, an x-ray radiation signal or a gamma radiation signal.

The control device may be adapted to produce wireless energy in the formof a train of energy pulses and the energy transfer device may beadapted to intermittently transfer the train of energy pulses for directuse in connection with the energising of the energy consuming componentsof the apparatus. Alternatively, the control device may be adapted tocontrol the energy transforming device to produce the energy of thesecond form in said train of energy pulses for direct use in connectionwith the operation of the adjustment device. The transferred energypreferably comprises electric energy. An implantable capacitor may beprovided for producing the train of energy pulses.

Where a capacitor is used in any of the above described embodiments itmay have a relatively low capacity, i.e. less than 0,1 μF, in order tobe small and suited for implantation.

Where the operation device comprises an implantable motor or pump foroperating the adjustment device, the energy transfer device may beadapted to directly power the motor or pump with transferred energy, atthe same time as the energy is transferred. Where a pump is used itshould not be a plunger type of pump, because a plunger pump is noisy,but may comprise a peristaltic or membrane pump.

As mentioned above the apparatus comprises a wireless remote control fornon-invasively controlling the operation device, which preferably iselectrically powered. Alternatively, the operation device is powered bymagnetic energy, non-magnetic energy, electromagnetic energy,non-electromagnetic energy, kinetic energy, non-kinetic energy, sonicenergy, non-sonic energy, thermal energy or non-thermal energy. However,the operation device may be unpowerable by permanent static magneticenergy. Any other kind of energy, such as electric, electromagneticenergy or a moving permanent magnetic energy, may be conceivable foroperating the adjustment device. As a result, the implanted restrictiondevice would not be accidentally adjusted if the patient comes close toany permanent magnet. Suitably, the operation device is adapted tonon-invasively operate the adjustment device.

Where the operation device comprises a hydraulic operation device it mayuse hydraulic fluid, the viscosity of which changes when the hydraulicfluid is exposed to energy, preferably electric energy, different thanthermal energy. However, use of hydraulic fluid of the kind having aviscosity that substantially increases when exposed to heat or amagnetic field, i.e. the hydraulic fluid would not become more viscouswhen exposed to heat or influenced by magnetic forces, should beavoided, because external heat sources or heat from the body when thepatient has fever and external magnetic sources might affect theimplanted components of the apparatus.

The adjustment device is may be operable to adjust the restrictiondevice to steplessly change the restriction of the blood flowpassageway. Furthermore, the adjustment device may be adapted tomechanically adjust the restriction device. Alternatively, it may beadapted to hydraulically adjust the restriction device by usinghydraulic means, which is devoid of hydraulic fluid of the kind having aviscosity that substantially increases when exposed to heat or amagnetic field.

In accordance with an embodiment of the invention, the apparatuscomprises a control device for controlling the restriction device. Thecontrol device may comprise an internal programmable control unitimplantable in the patient and, possibly an external control unitoutside the patient's body for programming the programmable internalcontrol unit. Alternatively, the external control unit may beprogrammable and wirelessly control the restriction device. The controldevice may be adapted to produce wireless energy for directly poweringthe operation device and/or for energizing other energy consumingcomponents of the apparatus.

At least one sensor for sensing at least one physical parameter of thepatient may conveniently be implanted in the patient. The sensor maypreferably sense as the physical parameter ejaculation, for example bysensing the pressure or flow in the patient's urethra, and either theinternal control unit or the external control unit of the control devicemay suitably control the restriction device to release the corporacavernosa or crura or the prolongations thereof in response to thesensor sensing ejaculation. For safety the restriction device mayrelease the corpora cavernosa or crura or the prolongations thereof inresponse to the sensor sensing for example an abnormally high pressurevalue. The internal control unit may directly control the restrictiondevice in response to signals from the sensor.

The pressure sensor may be any suitable known or conventional pressuresensor such as shown in U.S. Pat. Nos. 5,540,731, 4,846,181, 4738267,4571749, 4407296 or 3939823; or an NPC-102 Medical Angioplasty Sensor.

Either the internal control unit or the external control unit of thecontrol device may suitably control the restriction device to enlarge orclose the blood flow passageway. For safety the restriction device mayenlarge or open the blood flow passageway in response to the sensorsensing for example an abnormally high pressure value. The internalcontrol unit may directly control the restriction device in response tosignals from the sensor.

Wherever magnetic means is utilized according to the invention it maycomprise a permanent magnet and a magnetic material reed switch, orother suitable known or conventional magnetic means.

Where a source of energy is used the control device suitably is operablefrom outside the patient's body for controlling the source of energy torelease energy for use in connection with the operation of theadjustment device, when the adjustment device is implanted. The sourceof energy may be provided external to the patient's body, and thecontrol device may be adapted to control the external source of energyto release wireless energy for use in connection with the operation ofthe adjustment device.

The control device may control the source of energy to release magneticenergy, non-magnetic energy, electromagnetic energy, non-electromagneticenergy, kinetic energy, non-kinetic energy, sonic energy, non-sonicenergy, thermal energy or non-thermal energy, preferably in anon-invasive manner and for a determined time period and/or in adetermined number of energy pulses.

Where the implantable components of the apparatus comprise electricalcomponents they may include at least one or a single voltage levelguard. In this case, the electrical components suitably are devoid ofany current detector and/or charge level detector. Furthermore, theelectrical components may comprise a capacitor or accumulator, whereinthe charge and discharge of the capacitor or accumulator is controlledby use of the voltage level guard. As a result, there is no need for anyimplanted current detector and/or charge level detector for the controlof the capacitor, which makes the apparatus simple and reliable.

In accordance with an advantageous embodiment of the invention, theapparatus comprises an implantable switch for directly or indirectlyswitching the operation of the restriction device. The switch may beoperated by the energy supplied by the energy transmission devicementioned above to switch from an off mode, in which the implantablesource of energy mentioned above is not in use, to an on mode, in whichthe source of energy supplies energy for the operation of therestriction device.

In accordance with an alternative embodiment, the above mentioned aremote control may be employed for controlling the implantable source ofenergy, wherein the switch is operated by the energy supplied by theenergy transmission device to switch from an off mode, in which theremote control is prevented from controlling the source of energy andthe source of energy is not in use, to a standby mode, in which theremote control is permitted to control the source of energy to supplyenergy for the operation of the restriction device.

In accordance with another alternative embodiment, the switch isoperated by the energy supplied by the implantable energy transformingdevice mentioned above to switch from an off mode, in which the sourceof energy is not in use, to an on mode, in which the source of energysupplies energy for the operation of the restriction device.

In accordance with yet another alternative embodiment, the switch isoperated by the energy supplied by the energy transforming device toswitch from an off mode, in which the remote control is prevented fromcontrolling the source of energy and the source of energy is not in use,to a standby mode, in which the remote control is permitted to controlthe source of energy to supply energy for the operation of therestriction device.

Suitably, the restriction device is embedded in a soft or gel-likematerial, such as a silicone material having hardness less than 20Shore.

The energy transforming device may be designed to be implantedsubcutaneously or in the abdomen, thorax or cephalic region of thepatient.

The adjustment device may be adapted to adjust the restriction devicesuch that the restriction device provides a predetermined contraction ofthe blood flow passageway that is satisfactory for the patient.

All the above described various components, such as the motor, pump andcapacitor, may be combined in the different embodiments whereapplicable. Also the various functions described in connection with theabove embodiments of the invention may be used in differentapplications, where applicable. Specifically, the various remote controlfunctions described and all the various methods for supplying energy maybe used in any conceivable combination that is apparent to those skilledin the art.

The invention also provides a method for treating male sexual impotence,comprising surgically implanting in the body of a male impotent patientan adjustable restriction device engaging the corpora cavernosa or cruraor the prolongations thereof as a single unit, and when desired toachieve erection, adjusting the restriction device to temporarilycontract the corpora cavernosa or crura or the prolongations thereof torestrict the blood flow leaving the penis.

The invention also provides another method for treating male sexualimpotence, comprising surgically implanting in the body of a maleimpotent patient at least two adjustable restriction devices engagingthe respective corpora cavernosa or crura or the prolongations thereofas separate units of the patients penis, and when desired to achieveerection, non-manually without touching the skin of the patientadjusting the restriction devices to temporarily contract the corporacavernosa or crura or the prolongations thereof to restrict the bloodflow leaving the penis. The method may further comprise surgicallyimplanting one or more non-manually adjustble powered restrictiondevices engaging respective exit veins from the penis.

The method may further comprise implanting a source of energy in thepatient and providing a control device for controlling the source ofenergy from outside the patient's body to supply energy to therestriction device or alternatively energising energy consumingcomponents of the apparatus with wirelessly transmitted energy fromoutside the patient's body.

The invention also provides a laparascopic surgical method. Thus, thereis provided a method comprising the steps of placing at least twolaparascopical trocars in a male impotent patient's body, inserting adissecting tool through the trocars and dissecting an area of the penis,abdominal or pelvic or retroperitoneal surroundings, and placing anadjustable restriction device in the dissected area, so that therestriction device engages the corpora cavernosa or crura or theprolongations thereof.

The method may further comprise hydraulically adjusting the restrictiondevice in a non-manual manner. The restriction device may engage (a)both of the corpora cavernosa or crura or the prolongations thereof as asingle unit; or (b) one of the exit veins from the penis.

Alternatively, the method may further comprise implanting (a) a furtheradjustable restriction device, wherein the two restriction devicesengage the two corpora cavernosa or crura of the penis or theirprolongations, respectively, as separate units; or (b) severalrestriction devices engaging respective exit veins from the penis.

The method may further comprise implanting a source of energy in thepatient and providing a control device for controlling the source ofenergy from outside the patient's body to supply energy to therestriction device, and optionally also to other energy consumingcomponents of the apparatus, with wirelessly transmitted energy fromoutside the patient's body.

The operation device may preferably be powered with electricity andoperated in a non-manual manner.

The invention is described in more detail in the following withreference to the accompanying drawings, in which

FIGS. 1A-D are block diagrams of four different principal embodiments ofthe male sexual impotence treatment apparatus according to theinvention.

FIG. 2A-D are cross-sectional views of a pump mechanism according toFIG. 1C, which is designed to pump fluid in opposite directions bymechanically pushing a wall portion in only one direction.

FIG. 3 is a cross-sectional view of a reservoir having a variable volumecontrolled by a remote control motor, in accordance with a particularembodiment of the principal embodiment shown in FIG. 1B or 2B.

FIG. 4 is a cross-sectional view of a reservoir having a variable volumeadjustable by manual manipulation, in accordance with a particularembodiment of the principal embodiment shown in FIG. 1B or 1D.

FIG. 5A is a perspective view of a hydraulic, pneumatic or mechanicalservo system in accordance with a particular embodiment of the principalembodiment shown in FIG. 1D.

FIG. 5B is a cross-sectional view taken along line VB-VB of FIG. 5A.

FIG. 6 is a block diagram illustrating remote control components of thedevice of the invention;

FIG. 7 is a schematic view of exemplary circuitry used for the blockdiagram in FIG. 4;

FIG. 8 is a schematic view af a band with a cavity defining arestriction opening for use in accordance with the invention.

FIGS. 9A and 9B are schematic views of a first mechanical restrictiondevice for use in accordance with the invention;

FIGS. 10A and 10B are schematic views of a second mechanical restrictiondevice for use in accordance with the invention;

FIG. 11 is a schematic view of a third mechanical restriction device foruse in accordance with the invention;

FIG. 12A is a schematic front view of a fourth mechanical restrictiondevice for use in accordance with the invention;

FIGS. 12B and 12C are sectional views along the line A-A of FIG. 12A;

FIGS. 13A through 17B are five modifications of the embodiment of FIGS.12A-12C;

FIG. 18 is a view of an inflatable restriction device of the apparatusof the invention: and FIG. 19 illustrates the apparatus of the inventionimplanted in a patient.

Referring to the drawing figures, like reference numerals designateidentical or corresponding elements throughout the several figures.

FIGS. 1A-D are a block diagrams of four different embodiments of themale sexual impotence treatment apparatus according to the invention.FIG. 1A shows an elongated restriction member in the form of a band 2forming a loop which defines a restriction opening. The band 2 providesa restricted blood through-flow area in the corpora cavernosa whenapplied around the latter. FIG. 1A further shows a separate reservoir 4,a one way pump 6 and an alternate valve 8. FIG. 1B shows the band 2 anda fluid supply reservoir 10. FIG. 1C shows the band 2, a two-way pump 12and the reservoir 4. FIG. 1D shows a servo system with a first closedsystem controlling a second system. The servo system comprises the fluidsupply reservoir 10 and a servo reservoir 14. The servo reservoir 14controls a larger adjustable reservoir 16 which in connection with theband 2 applied around the corpora cavernosa varies the volume of acavity in the band, which in turn varies the restricted bloodthrough-flow area in the corpora cavernosa. Such a band 2 forming therestriction opening 3 is illustrated schematically in FIG. 8. The band 2comprises an adjustment device having an expandable/contractabe cavity 5which is expanded or contracted by supplying hydraulic fluid (e.g. fromreservoir 4, 6, 10, or 16), and the band 2 may be sutured in place,illustrated schematically at 7 in FIG. 8.

FIGS. 2A-D are cross-sectional views of a pump mechanism adapted to pumpfluid in both directions only by mechanically pushing a separate sealingwall portion 18 in one direction. FIG. 2A shows a piston 20 pushedforwards against a spring 22 towards the wall portion 18 and located ina pump housing 24 conducting fluid from a right upper fluid passage 26of the housing 24 to a left fluid passage 28 of the housing 24. A mainvalve 30 is open and a non-return valve 32 is closed. FIG. 2Billustrates the first pump movement in which the piston 20 has movedforwards and reaches the wall portion 18. FIG. 2C illustrates how thepiston 20 moves backwards by the action of the spring 22. The main valve30 is now closed and the non-return valve 32 is open for fluid from theright upper passage 26. FIG. 1D illustrates how the piston 20 is movedfurther downwards from its position according to FIG. 2B while pushingthe wall portion 18 downwardly against a second spring 34 that isstronger than spring 22, whereby fluid escapes from a right lower fluidpassage 36. When moving the piston 20 backwardly from the positionaccording to FIG. 2D, fluid enters the left fluid passage 28 and a valve38 in the lower right fluid passage 36 closes.

FIG. 3 is a cross-sectional view of a reservoir 40 defining a chamber42, the volume of which is variable and is controlled by a remotecontrolled electric motor 44, in accordance with FIG. 1B or 1D. Thereservoir 40 and the motor 44 are placed in a housing 46. The chamber 42is varied by moving a large wall 48. The wall 48 is secured to a nut 50,which is threaded on a spindle 52. The spindle 52 is rotated by themotor 44 via an angular gearing, which comprises two conical gear wheels54 and 56 in mesh with each other. The motor 44 is powered by a battery58 placed in the housing 46. An signal receiver 60 for controlling themotor 44 is also placed in the housing 46. Alternatively, the battery 58and the signal receiver 60 may be mounted in a separate place. The motor44 may also be powered by energy transferred from transmitted signals.

FIG. 4 is a cross-sectional view of a reservoir 62 defining a chamber64, the volume of which is variable and is controlled by manualmanipulation. A gable wall portion 66 of an open ended inner cylindricalhousing 68 is adapted to be pushed downwards to fit in a desired lockinggroove 70 of a plurality of locking grooves 70 on the mantle wall of thecylindrical housing 68, to reduce the volume of the chamber 64. Theinner cylindrical housing 68 is suspended by springs 72 and istelescopically applied on an outer cylindrical housing 74. When pushingthe inner cylindrical housing 68 it moves downwards relative to theouter cylindrical housing 74 causing the gable wall portion 66 torelease from the locking groove 70 and move upwards relative to theinner cylindrical housing 68. When the inner housing 68 is movedupwardly by the action of the springs 72 the volume of the chamber 64 isincreased.

FIGS. 5A and 5B show a servo means comprising a main ring-shaped fluidreservoir 76 defining a chamber 78, the volume of which is variable.Centrally positioned in the main ring-shaped reservoir 76 there is aservo fluid reservoir 80 defining a chamber 82, the volume of which isvariable. The chamber 82 of the servo reservoir 80 is substantiallysmaller than the chamber 78 of the main reservoir 76. The two reservoirs76 and 80 are situated between two opposite separate walls 84 and 86,and are secured thereto. When changing the amount of fluid in the servoreservoir 80, the two opposite walls 84,86 are moved towards or awayfrom each other, whereby the volume of the chamber 78 of the mainreservoir 76 is changed.

FIG. 6 shows the basic parts of a remote control system of the apparatusof the invention including the electric motor 44 of the embodiment shownin FIG. 3. In this case, the remote control system is based on thetransmission of electromagnetic wave signals, often of high frequenciesin the order of 100 kHz-1 gHz, through the skin 130 of the patient. InFIG. 6, all parts placed to the left of the skin 130 are located outsidethe patient's body and all parts placed to the right of the skin 130 areimplanted. Any suitable remote control system may be used.

An external signal transmitting antenna 132 is to be positioned close toa signal receiving antenna 134 implanted close to the skin 130. As analternative, the receiving antenna 134 may be placed for example insidethe abdomen of the patient. The receiving antenna 134 comprises a coil,approximately 1-100 mm, preferably 25 mm in diameter, wound with a verythin wire and tuned with a capacitor to a specific high frequency. Asmall coil is chosen if it is to be implanted under the skin of thepatient and a large coil is chosen if it is to be implanted in theabdomen of the patient. The transmitting antenna 132 comprises a coilhaving about the same size as the coil of the receiving antenna 134 butwound with a thick wire that can handle the larger currents that isnecessary. The coil of the transmitting antenna 132 is tuned to the samespecific high frequency as the coil of the receiving antenna 134.

An external control unit 136 comprises a microprocessor, a highfrequency electromagnetic wave signal generator and a power amplifier.The microprocessor of the control unit 136 is adapted to switch thegenerator on/off and to modulate signals generated by the generator tosend digital information via the power amplifier and the antennas132,134 to an implanted control unit 138. To avoid that accidentalrandom high frequency fields trigger control commands, digital signalcodes are used. A conventional keypad placed on the external controlunit 136 is connected to the microprocessor thereof. The keypad is usedto order the microprocessor to send digital signals to either increaseor decrease the size of the restriction opening defined by the loop ofthe restriction member 2. The microprocessor starts a command byapplying a high frequency signal on the antenna 132. After a short time,when the signal has energized the implanted parts of the control system,commands are sent to increase or decrease the size of the restrictionopening of the restriction member 2 in predefined steps. The commandsare sent as digital packets in the form illustrated below.

Start pattern, Command, Count, Checksum, 8 bits 8 bits 8 bits 8 bits

The commands are sent continuously during a rather long time period(e.g. about 30 seconds or more). When a new increase or decrease step isdesired the Count byte is increased by one to allow the implantedcontrol unit 138 to decode and understand that another step is demandedby the external control unit 136. If any part of the digital packet iserroneous, its content is simply ignored.

Through a line 140, an implanted energiser unit 126 draws energy fromthe high frequency electromagnetic wave signal received by the receivingantenna 134. The energiser unit 126 stores the energy in a power supply,such as a large capacitor, powers the control unit 138 and powers theelectric motor 44 via a line 142.

The control unit 138 comprises a demodulator and a microprocessor. Thedemodulator demodulates digital signals sent from the external controlunit 136. The microprocessor of the control unit 138 receives thedigital packet, decodes it and, provided that the power supply of theenergiser unit 126 has sufficient energy stored, sends a signal via asignal line 144 to the motor 44 to either increase or decrease the sizeof the restriction opening of the restriction member 2 depending on thereceived command code.

Alternatively, the energy stored in the power supply of the energiserunit may only be used for powering a switch, and the energy for poweringthe motor 44 may be obtained from another implanted power source ofrelatively high capacity, for example a battery. In this case the switchis adapted to connect the battery to the control unit 138 in an on modewhen the switch is powered by the power supply and to keep the batterydisconnected from the control unit in a standby mode when said switch isunpowered.

With reference to FIG. 7, the remote control system schematicallydescribed above will now be described in accordance with a more detailedembodiment. The external control unit 136 comprises a microprocessor146, a signal generator 148 and a power amplifier 150 connected thereto.The microprocessor 146 is adapted to switch the signal generator 148on/off and to modulate signals generated by the signal generator 148with digital commands that are sent to implanted components of therestriction device. The power amplifier 150 amplifies the signals andsends them to the external signal transmitting antenna 132. The antenna132 is connected in parallel with a capacitor 152 to form a resonantcircuit tuned to the frequency generated by the signal generator 148.

The implanted signal receiving antenna coil 134 forms together with acapacitor 154 a resonant circuit that is tuned to the same frequency asthe transmitting antenna 132. The signal receiving antenna coil 134induces a current from the received high frequency electromagnetic wavesand a rectifying diode 160 rectifies the induced current, which chargesa storage capacitor 158. A coil 156 connected between the antenna coil134 and the diode 160 prevents the capacitor 158 and the diode 160 fromloading the circuit of the signal receiving antenna 134 at higherfrequencies. Thus, the coil 156 makes it possible to charge thecapacitor 158 and to transmit digital information using amplitudemodulation A capacitor 162 and a resistor 164 connected in parallel anda diode 166 forms a detector used to detect amplitude modulated digitalinformation. A filter circuit is formed by a resistor 168 connected inseries with a resistor 170 connected in series with a capacitor 172connected in series with the resistor 168 via ground, and a capacitor174, one terminal of which is connected between the resistors 168,170and the other terminal of which is connected between the diode 166 andthe circuit formed by the capacitor 162 and resistor 164. The filtercircuit is used to filter out undesired low and high frequencies. Thedetected and filtered signals are fed to an implanted microprocessor 176that decodes the digital information and controls the motor 44 via anH-bridge 178 comprising transistors 180,182,184 and 186. The motor 44can be driven in two opposite directions by the H-bridge 178.

The microprocessor 176 also monitors the amount of stored energy in thestorage capacitor 158. Before sending signals to activate the motor 44,the microprocessor 176 checks whether the energy stored in the storagecapacitor 158 is enough. If the stored energy is not enough to performthe requested operation, the microprocessor 176 waits for the receivedsignals to charge the storage capacitor 158 before activating the motor44.

FIGS. 9A and 9B show an embodiment of the apparatus of the inventioncomprising a restriction device 202 having an elongated flexiblerestriction member 204, such as a belt, a cord or the like. The flexiblemember 204 extends in a loop around the corpora cavernosa.(Alternatively, the flexible member 204 may comprise two separate partson opposite sides of the corpora cavernosa.) One portion 204A of member204 is attached to a frame 208 and another portion 204B of member 204opposite portion 204A in the loop of the flexible member 204 isconnected to an adjustment device 210, which is fixed to the frame 208.The adjustment device 210 pulls the flexible member 204 away fromportion 204A to squeeze the corpora cavernosa between two oppositelengths of the flexible member 204 to thereby restrict the blood flowleaving the penis, see FIG. 9A, and releases the corpora cavernosa fromthe flexible member 204 to thereby increase the blood flow leaving thepenis, see FIG. 9B.

FIGS. 10A and 10B show an embodiment of the apparatus of the inventioncomprising a restriction device 212 having two plate or bar elements 214on opposite sides of the corpora cavernosa 206. An adjustment device 216moves the elements 212 in parallel towards each other to squeeze thecorpora cavernosa 206 between the elements 212 to thereby restrict theblood flow leaving the penis, see FIG. 10A, and moves the elements 212away from each other to increase the blood flow leaving the penis, seeFIG. 10B.

FIG. 11 shows an embodiment of the apparatus of the invention comprisinga restriction device 218 having two articulated clamping elements 220positioned on opposite sides of the corpora cavernosa 206. An adjustmentdevice 222 moves the clamping elements 220 toward each other to clampthe corpora cavernosa 206 between the clamping elements 220 to therebyrestrict the blood flow leaving the penis, and moves the clampingelements 220 away from each other to release the corpora cavernosa 206from the clamping elements 220 to thereby increase the blood flowleaving the penis.

FIGS. 12A, 12B and 12C show an embodiment of the apparatus of theinvention comprising a restriction device 224 having three bendingmembers in the form of cylindrical rollers 226, 228 and 230 displacedrelative one another in a row along the corpora cavernosa 206 andpositioned alternately on opposite sides of the corpora cavernosa 206.(Alternatively, each roller 226, 228 and 230 may take the shape of anhour-glass.) An adjustment device 232 moves the two outer rollers226,230 laterally against the corpora cavernosa 206 in one direction andthe intermediate roller 228 against the corpora cavernosa 206 in theopposite direction to bend the corpora cavernosa to thereby restrict theblood flow leaving the penis, see FIG. 12B. To release the corporacavernosa from the rollers 226-230, the adjustment device 232 moves therollers 226-230 away from the corpora cavernosa 206, see FIG. 12C.

FIGS. 13A through 17B schematically illustrates modifications of theabove embodiment according to FIGS. 12A-12C. Thus, FIGS. 13A and 13Bshow an embodiment similar to that of FIGS. 12A-12C except that thebending members are oval and not rotatable. FIGS. 14A and 14B show anembodiment similar to that of FIGS. 13A and 13B except that the ovalbending members are rotatable to squeeze the corpora cavernosa, see FIG.14B, and to release the corpora cavernosa, see FIG. 14A. FIGS. 15A and15B show an embodiment similar to that of FIGS. 12A-12C except that theintermediate roller has a changeable diameter to squeeze the corporacavernosa, see FIG. 15B, and to release the corpora cavernosa, see FIG.15A. FIGS. 16A and 16B show an embodiment similar to that of FIGS.10A-10C except that the elements are replaced by two cylindrical rollerspositioned on opposite sides of the corpora cavernosa. Finally, FIGS.17A and 17B show an embodiment substantially similar to that of FIGS.16A and 16B except that the restriction device is turned 90 to form anS-shaped curvature of the corpora cavernosa.

FIG. 18 shows an example of a hydraulic restriction device 234 for usein accordance with the invention. The restriction device 234 comprisesan elongated restriction member 236 having an inflatable cavity 238. Atube 240 connects the cavity 238 to a hydraulic fluid reservoir, notshown. The restriction member 236 may be wrapped around the corporacavernosa. Alternatively, two restriction members 236 may be wrappedaround the respective crura.

FIG. 19 schematically illustrates how any of the above-describedembodiments of the male sexual impotence treatment apparatus of theinvention can be implanted in a patient. Thus, an implanted adjustablehydraulic restriction device 234 extends almost completely around thecorpora cavernosa 242 and the urethra 244 to be capable of contractingthe corpora cavernosa 242 as a single unit. An adjustment device in theform of an inflatable cavity in the restriction device 234 is adapted toadjust the restriction device 234 so that the blood flow leaving thepenis is restricted. An implanted assembly 246 includes a hydraulicfluid reservoir and a hydraulic operation device (which may include apump) for distributing hydraulic fluid between the reservoir and theinflatable/contractible cavity of the restriction device 234 via a fluidconduit 240.

A wireless remote control of the apparatus comprises an external signaltransmitter 248, which may comprise a hand-held unit, and an implantedsignal receiver, which is incorporated in the implanted assembly 246.The assembly 246 further includes a control unit for controlling therestriction device 234 in response to a control signal from the externaltransmitter. The signal receiver of the assembly 246 further includes anenergiser unit which transforms energy from the control signaltransmitted by the external transmitter into electric energy forpowering the operation device of the assembly 246 and for energyconsuming implanted components of the apparatus.

A pressure sensor 250 is implanted for sensing the pressure on therestriction device 234. The control unit of the assembly 246 controlsthe operation device of the assembly 246 to operate the adjustmentdevice 234 to adjust the restriction device 234 so that the corporacavernosa is released in response to the pressure sensor 250 sensing anabnormal high pressure.

There is a number of conceivable alternative embodiments of theinvention that give the same result as the above-described embodiments.For example, the microprocessor of the external and implanted,respectively, control units may be replaced by discrete components. Thepower amplifier of the external control unit may be omitted if thesignals generated by the signal generator are strong enough. Therefore,the invention is to be accorded the broadest interpretation of theappended claims to encompass all equivalent structures and assemblies.

1. A male sexual impotence treatment apparatus, comprising an adjustablerestriction device implantable in a male patient, who suffers fromsexual impotence, for engaging the corpora cavernosa or crura or theprolongations thereof of the patient's penile tissue; an implantableadjustment device for adjusting the restriction device to temporarilycontract the corpora cavernosa or crura or the prolongations thereof torestrict the blood flow leaving the penis; an implantable powered,non-manual operation device for operating the adjustment device; and animplantable reservoir containing hydraulic fluid, wherein the operationdevice operates the adjustment device by distributing the hydraulicfluid to and from the reservoir.
 2. A male sexual impotence treatmentapparatus according to claim 1, wherein the restriction device isadapted to restrict the corpora cavernosa or crura or the prolongationsthereof as a single unit.
 3. An apparatus according to claim 1, whereinthe reservoir contains a predetermined amount of hydraulic fluid.
 4. Anapparatus according to claim 1, wherein the adjustment device comprisesan expandable cavity in the restriction device, the corpora cavernosa orcrura or the prolongation thereof being contracted upon expansion of thecavity and released upon contraction of the cavity, and the hydraulicoperation device is adapted to distribute hydraulic fluid from thereservoir to expand the cavity, and to distribute hydraulic fluid fromthe cavity to the reservoir to contract the cavity.
 5. An apparatusaccording to claim 4, wherein the reservoir defines a chamber for saidpredetermined amount of fluid and the operation device is adapted tochange the size of the chamber.
 6. An apparatus according to claim 5wherein the operation device comprises first and second wall portions ofthe reservoir and is adapted to provide relative displacement betweenthe first and second wall portions of the reservoir, in order to changethe volume of the chamber.
 7. An apparatus according to claim 6, whereinthe operation device is adapted to provide said relative displacement inresponse to the pressure in the reservoir.
 8. An apparatus according toclaim 7, wherein the operation device comprises a pressure controlledhydraulic operation device.
 9. An apparatus according to claim 8,further comprising an alarm adapted to generate an alarm signal inresponse to the lapse of a predetermined time period during which thepressure controlling the hydraulic operation device exceeds apredetermined high value.
 10. An apparatus according to claim 6, whereinthe first and second wall portions of the reservoir are displaceablerelative to each other by magnetic means, hydraulic means, or electriccontrol means, or a combination thereof.
 11. An apparatus according toclaim 6, wherein the operation device is adapted to distribute fluidfrom the reservoir to the cavity of the restriction device in responseto a predetermined first displacement of the first wall portion of thereservoir relative to the second wall portion of the reservoir and todistribute fluid from the cavity to the reservoir in response to apredetermined second displacement of the first wall portion relative tothe second wall portion.
 12. An apparatus according to claim 4, whereinthe operation device comprises a pump adapted to pump fluid between thereservoir to the cavity of the restriction device.
 13. An apparatusaccording to claim 12, wherein the pump comprises a first activationmember for activating the pump to pump fluid from the reservoir to thecavity of the restriction device and a second activation member foractivating the pump to pump fluid from the cavity to the reservoir. 14.An apparatus according to claim 13, wherein at least one of theactivation members is adapted to operate when subjected to apredetermined external pressure.
 15. An apparatus according to claim 13,wherein at least one of the first and second activating members areoperable by magnetic means, hydraulic means, electric control means ormanual manipulation means, or a combination thereof.
 16. An apparatusaccording to claim 1, wherein the operation device comprises a servomeans.
 17. An apparatus according to claim 6 wherein the operationdevice comprises a reverse servo.
 18. A male sexual impotence treatmentapparatus, comprising an adjustable restriction device implantable in amale patient, who suffers from sexual impotence, for engaging thecorpora cavernosa or crura or the prolongations thereof of the patient'spenile tissue, an implantable adjustment device for adjusting therestriction device to temporarily contract the corpora cavernosa orcrura or the prolongations thereof to restrict the blood flow leavingthe penis, and an implantable operation device for operating theadjustment device, characterised in that the operation device comprisesa servo means.
 19. An apparatus according to claim 18, wherein theoperation device is powered.
 20. An apparatus according to claim 18,wherein the operation device is manually operated.
 21. An apparatusaccording to claim 16, wherein the servo means comprises a motor,preferably an electric motor.
 22. An apparatus according to claim 21,wherein the motor is reversible.
 23. An apparatus according to claim 21,further comprising a gearing connected between the motor and theadjustment device.
 24. An apparatus according to claim 18, furthercomprising an implantable reservoir defining a chamber for hydraulicfluid, wherein the operation device is adapted to operate the adjustmentdevice by using the hydraulic fluid of the reservoir.
 25. An apparatusaccording to claim 1, wherein the reservoir contains a predeterminedamount of hydraulic fluid.
 26. An apparatus according to claim 18wherein the servo means comprises a reverse servo.
 27. An apparatusaccording to claim 17, wherein the reservoir comprises first and secondwall portions and the reverse servo is adapted to provide relativedisplacement between the first and second wall portions of thereservoir, in order to change the volume of the reservoir.
 28. Anapparatus according to claim 27 and, wherein the reverse servo device isadapted to provide said relative displacement in response to thepressure in the reservoir.
 29. An apparatus according to claim 18,wherein the servo means comprises a pressure controlled servo means. 30.An apparatus according to claim 29, further comprising an alarm adaptedto generate an alarm signal in response to the lapse of a predeterminedtime period during which the pressure controlling the servo meansexceeds a predetermined high value.
 31. An apparatus according to claim26, wherein the reverse servo comprises magnetic means, electric meansor manual manipulation means or a combination thereof.
 32. An apparatusaccording to claim 27, wherein the reverse servo comprises hydraulicmeans.
 33. An apparatus according to claim 32, wherein the reverse servofurther comprises a servo reservoir defining a chamber containing servofluid, and the operation device comprise first and second wall portionsof the servo reservoir, which are displaceable relative to each other tochange the volume of the chamber of the servo reservoir.
 34. Anapparatus according to claim 33, wherein the first and second wallportions of the servo reservoir are displaceable relative to each otherby magnetic means, hydraulic means, or electric control means.
 35. Anapparatus according to claim 32, wherein the reverse servo comprises aservo reservoir and a fluid supply reservoir connected in a closedsystem and containing a further predetermined amount of fluid.
 36. Anapparatus according to claim 35, wherein the fluid supply reservoirdefines a chamber for the further predetermined amount of fluid and thehydraulic operation device is adapted to change the volume of thechamber and thereby control the amount of fluid in the servo reservoir.37. An apparatus according to claim 36, wherein the fluid supplyreservoir comprises first and second wall portions, which aredisplaceable relative to each other to change the volume of the chamberof the fluid supply reservoir.
 38. An apparatus according to claim 37,wherein the fluid supply reservoir increases the amount of fluid in theservo reservoir in response to a predetermined first displacement of thefirst wall portion of the fluid supply reservoir relative to the secondwall portion of the fluid supply reservoir and decreases the amount offluid in the servo reservoir in response to a predetermined seconddisplacement of the first wall portion of the fluid supply reservoirrelative to the second wall portion of the fluid supply reservoir.
 39. Amale sexual impotence treatment apparatus comprising: an adjustablerestriction device implantable in a male patient, who suffers fromsexual impotence, for engaging the corpora cavernosa or crura or theprolongations thereof of the patient's penile tissue; an implantableadjustment device for adjusting the restriction device to temporarilycontract the corpora cavernosa or crura or the prolongations thereof torestrict the blood flow leaving the penis; an implantable powered,non-manual operation device for operating the adjustment device; andwherein the adjustment device comprises a hydraulic adjustment device,and further comprising a reservoir implantable in the patient andcontaining a predetermined amount of hydraulic fluid, and a conduitproviding fluid connection between the reservoir and the hydraulicadjustment device, the operation device being adapted to operate thehydraulic adjustment device by distributing hydraulic fluid through theconduit between the reservoir and the hydraulic adjustment device, theconduit and hydraulic adjustment device being devoid of any non-returnvalve to permit free flow of hydraulic fluid in both directions in theconduit.
 40. An apparatus according to claim 39, wherein the reservoirforms a fluid chamber with a variable volume, and the operation deviceis adapted to distribute fluid from the chamber to the adjustment deviceby reduction of the volume of the chamber and to withdraw fluid from theadjustment device by expansion of the volume of the chamber.
 41. Anapparatus according to claim 40, wherein the operation device comprisesa motor or a pump.
 42. An apparatus according to claim 40, wherein theoperation device comprises a movable wall of the reservoir for changingthe volume of the chamber.
 43. An apparatus according to claim 42,wherein the operation device is adapted to change the volume of thechamber by moving the movable wall in response to the pressure in thechamber.
 44. An apparatus according to claim 5, further comprising aninjection port subcutaneously implantable in the patient and in fluidcommunication with the chamber.
 45. An apparatus according to claim 44,wherein the injection port is integrated in the reservoir.
 46. A malesexual impotence treatment apparatus comprising: an adjustablerestriction device implantable in a male patient, who suffers fromsexual impotence, for engaging the corpora cavernosa or crura or theprolongations thereof of the patient's penile tissue; an implantableadjustment device for adjusting the restriction device to temporarilycontract the corpora cavernosa or crura or the prolongations thereof torestrict the blood flow leaving the penis; an implantable powered,non-manual operation device for operating the adjustment device; andwherein the restriction device comprises an elongated restriction memberand forming means for forming the restriction member into at least asubstantially closed loop around the corpora cavernosa or crura or theprolongations thereof, the loop defining a restriction opening, wherebythe adjustment device is adapted to adjust the restriction member in theloop to change the size of the restriction opening.
 47. An apparatusaccording to claim 46, wherein the forming means forms the restrictionmember into a loop having a predetermined size or a size selected fromseveral predetermined sizes.
 48. An apparatus according to claim 46,wherein the adjustment device is adapted to change the size of therestriction opening such that the outer circumferential confinementsurface of the restriction member is changed.
 49. An apparatus accordingto claim 46, wherein the adjustment device is adapted to change the sizeof the restriction opening such that the outer circumferentialconfinement surface of the restriction member is unchanged.
 50. Anapparatus according to claim 46, wherein the restriction member isnon-inflatable, and the adjustment device is adapted to adjust therestriction member in said loop.
 51. An apparatus according to claim 34,wherein the adjustment device mechanically adjusts the restrictionmember.
 52. An apparatus according to claim 50, wherein the adjustmentdevice hydraulically adjusts the non-inflatable restriction member. 53.An apparatus according to claim 51, wherein the elongated restrictionmember is flexible, and the adjustment device is adapted to pull a firstportion of the flexible restriction member from a second portion of theflexible restriction member opposite the first portion in the loop tosqueeze the corpora cavernosa or crura or the prolongations thereofbetween two opposite lengths of the elongated flexible restrictionmember to restrict the blood flow leaving the penis, and to release thecorpora cavernosa or crura or the prolongations thereof from theflexible restriction member to restore the blood flow.
 54. An apparatusaccording to claim 1, wherein the adjustment device mechanically adjuststhe restriction device.
 55. An apparatus according to claim 1, whereinthe restriction device comprises at least two elements to be placed ondifferent sides of the corpora cavernosa or crura or the prolongationsthereof, and the adjustment device is adapted to squeeze the corporacavernosa or crura or the prolongations thereof between the elements torestrict the blood flow leaving the penis, and to release the corporacavernosa or crura or the prolongations thereof from the elements torestore the blood flow.
 56. An apparatus according to claim 1, whereinthe restriction device comprises at least two articulated clampingelements to be positioned on opposite or different sides of the corporacavernosa or crura or the prolongations thereof, and the adjustmentdevice is adapted to turn the clamping elements toward each other toclamp the corpora cavernosa or crura or the prolongations thereofbetween the clamping elements to restrict the blood flow leaving thepenis, and to turn the clamping elements away from each other to releasethe corpora cavernosa or crura or the prolongations thereof from theelements to restore the blood flow.
 57. An apparatus according to claim1, wherein the restriction device is adapted to bend a portion of thecorpora cavernosa or crura or the prolongations thereof.
 58. Anapparatus according to claim 41, wherein the restriction devicecomprises at least two bending members to be positioned on oppositesides of the corpora cavernosa or crura or the prolongations thereof andto be displaced relative to each other along the corpora cavernosa orcrura or the prolongations thereof in the corpora cavernosa or crura orthe prolongations thereof, and the adjustment device is adapted to movethe bending members against the corpora cavernosa or crura or theprolongations thereof to bend them to restrict the blood flow leavingthe penis, and to move the bending members away from the corporacavernosa or crura or the prolongations thereof to release them from thebending members to restore the blood flow.
 59. An apparatus according toclaim 42, wherein the bending members comprise rollers.
 60. An apparatusaccording to claim 1, wherein the restriction device is adapted torotate a portion of the corpora cavernosa or crura or the prolongationsthereof.
 61. An apparatus according to claim 1, further comprising awireless remote control for non-invasively controlling the hydraulicoperation device.
 62. An apparatus according to claim 61, wherein theremote control comprises an external wireless hand-held remote controlunit which is manually operable by the patient to control therestriction device to squeeze or release the corpora cavernosa or cruraor the prolongations thereof.
 63. An apparatus according to claim 62,wherein the remote control comprises an external signal transmitter,receiver or transceiver and a signal receiver, transmitter ortransceiver implantable in the patient.
 64. An apparatus according toclaim 63, wherein the signal receiver and/or transmitter comprises acontrol unit adapted to control the operation device in response to acontrol signal received from the signal transmitter.
 65. An apparatusaccording to claim 64, further comprising an implantable energizer unitfor providing energy to energy consuming implantable components of theapparatus.
 66. A male sexual impotence treatment apparatus comprising:an adjustable restriction device implantable in a male patient, whosuffers from sexual impotence, for engaging the corpora cavernosa orcrura or the prolongations thereof of the patient's penile tissue; animplantable adjustment device for adjusting the restriction device totemporarily contract the corpora cavernosa or crura or the prolongationsthereof to restrict the blood flow leaving the penis; an implantablepowered, non-manual operation device for operating the adjustmentdevice; and wherein the operation device comprises a motor for operatingthe adjustment device.
 67. An apparatus according to claim 65, whereinthe control unit is adapted to power the motor with energy provided bythe energizer unit in response to a control signal received from thesignal transmitter.
 68. An apparatus according to claim 61, wherein theremote control comprises wireless energy transfer means for transferringenergy from outside the patient's body to energy consuming implantablecomponents of the apparatus.
 69. An apparatus according to claim 65,wherein the energy transfer means comprises an implantable energizerunit, which is adapted to transform energy from the control signal, asit is transmitted to the signal receiver, into electric energy.
 70. Anapparatus according to claim 68, wherein the operation device comprisesa motor, and the wireless energy transfer means is adapted to directlypower the motor with transferred energy.
 71. An apparatus according toclaim 69, wherein the energy transferred by the wireless energy transfermeans comprises a signal.
 72. An apparatus according to claim 71,wherein the signal comprises a wave signal.
 73. An apparatus accordingto claim 69, wherein the energy transferred by the wireless energytransfer means comprises an electric field or a magnetic field or acombination thereof.
 74. An apparatus according to claim 71, wherein thesignal is analog or digital or a combination thereof.
 75. An apparatusaccording to claim 63, wherein the signal transmitter and signalreceiver are adapted to transmit and receive an analog or digital signalor a combination thereof.
 76. An apparatus according to claim 75,wherein the signal comprises analog or digital pulses.
 77. An apparatusaccording to claim 74, wherein the analog or digital signal comprises amagnetic field or an electric field or a combination thereof.
 78. Anapparatus according to claim 63, wherein the signal transmitter andsignal receiver are adapted to transmit and receive a wave signal. 79.An apparatus according to claim 71, wherein the wave signal comprises anelectromagnetic wave signal, a sound wave signal or a carrier wavesignal for a remote control signal or a combination thereof.
 80. Anapparatus according to claim 79, wherein the carrier signal isfrequency, amplitude or frequency and amplitude modulated.
 81. Anapparatus according to claim 71 wherein the energy transfer meanstransfers the energy from the signal into a direct, pulsating direct oralternating current or a combination thereof.
 82. An apparatus accordingto claim 61, wherein the remote control is capable of obtaininginformation related to important parameters of the apparatus from insidethe patient's body and of commanding the adjustment device to adjust therestriction device in response to obtained information.
 83. An apparatusaccording to claim 61, wherein the remote control is capable ofobtaining information related to the contraction of the corporacavernosa or crura or the prolongations thereof and of commanding theadjustment device to adjust the restriction device in response toobtained information.
 84. An apparatus according to claim 1, furthercomprising an implantable source of energy for powering the operationdevice and/or for energizing other energy consuming components of theapparatus, wherein the energy from the source of energy is releasablefrom outside the patient's body.
 85. A male sexual impotence treatmentapparatus comprising: an adjustable restriction device implantable in amale patient, who suffers from sexual impotence, for engaging thecorpora cavernosa or crura or the prolongations thereof of the patient'spenile tissue; an implantable adjustment device for adjusting therestriction device to temporarily contract the corpora cavernosa orcrura or the prolongations thereof to restrict the blood flow leavingthe penis; an implantable powered, non-manual operation device foroperating the adjustment device; and an energy transmission device forwireless transmission of energy.
 86. An apparatus according to claim 85,wherein the energy transmission device transmits energy of a first form,and further comprising an energy transforming device implantable in thepatient for transforming the energy of the first form into energy of asecond form, to be supplied to the source of energy and/or otherimplantable energy consuming parts of the apparatus.
 87. An apparatusaccording to claim 86, wherein the energy of the second form isdifferent than the energy of the first form.
 88. An apparatus accordingto claim 86, wherein the energy transmission device functions differentfrom the energy transforming device.
 89. An apparatus according to claim85, further comprising an implantable motor or pump for operating theadjustment device, wherein the energy transmission device is adapted totransmit wireless energy in the form of an magnetic field orelectromagnetic waves or field for direct power of the motor or pump, asthe wireless energy is being transmitted.
 90. An apparatus according toclaim 85, wherein the energy transmission device transmits energy by atleast one signal separate from the control signal.
 91. An apparatusaccording to claim 86, further comprising an implantable stabiliser forstabilising the energy of the first or second form.
 92. An apparatusaccording to claim 91, wherein the energy of the second form compriseselectric current and the stabiliser comprises at least one capacitor.93. An apparatus according to claim 84, wherein the source of energycomprises a battery, accumulator, capacitor or a combination thereof.94. An apparatus according to claim 1, further comprising a controldevice adapted to produce wireless energy for directly powering theoperation device and/or for energizing other energy consuming componentsof the apparatus.
 95. An apparatus according to claim 1, furthercomprising an implantable energy transforming device for transformingwireless energy directly or indirectly into energy different than thewireless energy for operation of the restriction device.
 96. Anapparatus according to claim 94, wherein the wireless energy comprises awave signal including a sound wave signal, an ultrasound wave signal, anelectromagnetic wave signal, an infrared light signal, a visible lightsignal, an ultra violet light signal, a laser light signal, a micro wavesignal, a radio wave signal, an x-ray radiation signal or a gammaradiation signal.
 97. An apparatus according to claim 1, furthercomprising an energy transfer means for wireless transfer of energy fromoutside the patient's body to the operation device or adjustment deviceand/or other energy consuming implantable components of the apparatus.98. An apparatus according to claim 94, wherein the control device isadapted to produce wireless energy in the form of a train of energypulses.
 99. An apparatus according to claim 97, wherein the energytransfer means is adapted to intermittently transfer the energy in theform of a train of energy pulses for direct use in connection with theenergizing of the energy consuming components of the apparatus.
 100. Anapparatus according to claim 94 wherein the control device is adapted tocontrol the energy transforming device to produce the energy of thesecond form in a train of energy pulses for direct use in connectionwith the operation of the adjustment device.
 101. An apparatus accordingto claim 99, wherein the energy transfer device is adapted to transferelectric energy, and further comprising an implantable capacitor forproducing the train of energy pulses.
 102. An apparatus according toclaim 101, wherein the capacitor has a capacity less than 0.1 μF. 103.An apparatus according to claim 97, further comprising an implantablemotor or pump for operating the adjustment device, wherein the energytransfer means is adapted to directly power the motor or pump withtransferred energy.
 104. An apparatus according to claim 103, whereinthe pump is not a plunger type of pump.
 105. An apparatus according toclaim 1, wherein the adjustment device is adapted to adjust therestriction device in a non-manual, non-thermal or non-magnetic manner.106. An apparatus according to claim 63, further comprising a wirelessremote control for non-invasively controlling the operation device. 107.An apparatus according to claim 1, wherein the operation device iselectrically powered.
 108. An apparatus according to claim 1, whereinthe operation device is unpowerable by static permanent magnetic energy.109. An apparatus according to claim 1, wherein the operation device isadapted to non-invasively operate the adjustment device.
 110. Anapparatus according to claim 1, wherein the adjustment device isoperable to adjust the restriction device to steplessly change thecontraction of the corpora cavernosa or crura or the prolongationsthereof.
 111. An apparatus according to claim 1, wherein the operationdevice comprises a hydraulic operation device which uses hydraulicfluid, the viscosity of which changes when the hydraulic fluid isexposed to energy different than thermal energy.
 112. An apparatusaccording to claim 111, wherein the viscosity of the hydraulic fluidchanges when the fluid is exposed to electric energy.
 113. An apparatusaccording to claim 1, wherein the adjustment device is adapted tomechanically adjust the restriction device, or adapted to hydraulicallyadjust the restriction device by using hydraulic means which is devoidof hydraulic fluid of the kind having a viscosity that substantiallyincreases when exposed to heat or a magnetic field.
 114. An apparatusaccording to claim 1, further comprising a control device forcontrolling the restriction device.
 115. An apparatus according to claim114, wherein the control device comprises an internal control unitimplantable in the patient for controlling the restriction device. 116.An apparatus according to claim 115, wherein the internal control unitis programmable.
 117. An apparatus according to claim 116, wherein thecontrol device comprises an external control unit outside the patient'sbody, and wherein the implantable internal control unit is programmableby the external control unit.
 118. An apparatus according to claim 114,wherein the control device comprises an external control unit outsidethe patient's body for wirelessly controlling the restriction device.119. An apparatus according to claim 118, wherein the external controlunit is programmable.
 120. An apparatus according to claim 1, furthercomprising at least one implantable sensor for sensing at least onephysical parameter of the patient.
 121. An apparatus according to claim120, wherein the sensor is adapted to directly or indirectly sense asthe physical parameter the horizontal position of the patient.
 122. Anapparatus according to claim 120, wherein the sensor comprises apressure sensor for directly or indirectly sensing as the physicalparameter the pressure against the restriction device or part of thehuman body.
 123. An apparatus according to claim 122, wherein therestriction device is adapted to enlarge the blood flow passageway inthe corpora cavernosa or crura or the prolongations thereof in responseto the pressure sensor sensing a predetermined pressure.
 124. Anapparatus according to claim 120, further comprising a control devicefor controlling the restriction device in response to signals from thesensor.
 125. An apparatus according to claim 124, wherein the controldevice comprises an internal control unit implantable in the patient anddirectly controlling the restriction device in response to signals fromthe sensor.
 126. An apparatus according to claim 125, wherein thecontrol device comprises an external control unit outside the patient'sbody for controlling the restriction device in response to signals fromthe sensor.
 127. An apparatus according to claim 125, wherein thecontrol device comprises an external control unit outside the patient'sbody for manually controlling the restriction device in response toinformation from the sensor.
 128. An apparatus according to claim 114,further comprising an implantable source of energy, wherein the controldevice is operable from outside the patient's body for controlling thesource of energy to release energy for use in connection with theoperation of the prosthesis, when the prosthesis is implanted.
 129. Anapparatus according to claim 128, wherein the source of energy isintended to be external to the patient's body, and the control device isadapted to control the external source of energy to release wirelessenergy for use in connection with the operation of the prosthesis. 130.An apparatus according to claim 128, wherein the control device controlsthe source of energy to release magnetic energy, non-magnetic energy,electromagnetic energy, non-electromagnetic energy, kinetic energy,non-kinetic energy, sonic energy, non-sonic energy, thermal energy ornon-thermal energy.
 131. An apparatus according to claim 1, wherein theoperation device is powered by magnetic energy, non-magnetic energy,electromagnetic energy, non-electromagnetic energy, kinetic energy,non-kinetic energy, sonic energy, non-sonic energy, thermal energy ornon-thermal energy.
 132. An apparatus according to claim 128, whereinthe control device controls the source of energy to release energy for adetermined time period.
 133. An apparatus according to claim 128,wherein the control device controls the source of energy to releaseenergy in a determined number of energy pulses.
 134. An apparatusaccording to claim 128, wherein the control device is adapted to controlthe source of energy to release energy in a non-invasive manner.
 135. Anapparatus according to claim 1, further comprising implantableelectrical components including at least one voltage level guard. 136.An apparatus according to claim 1, further comprising implantableelectrical components including a single voltage level guard.
 137. Anapparatus according to claim 136, wherein the electrical components aredevoid of any current detector and/or charge level detector.
 138. Anapparatus according to claim 84, further comprising an implantablecapacitor or accumulator, wherein the charge or discharge of thecapacitor or accumulator is controlled by use of the voltage levelguard.
 139. An apparatus according to claim 64, wherein the controlsignal comprises a wave signal including a sound wave signal, anultrasound wave signal, an electromagnetic wave signal, an infraredlight signal, a visible light signal, an ultra violet light signal, alaser light signal, a micro wave signal, a radio wave signal, an x-rayradiation signal or a gamma radiation signal.
 140. An apparatusaccording to claim 1, further comprising a switch implantable in thepatient for directly or indirectly switching the operation of therestriction device.
 141. An apparatus according to claim 140, furthercomprising a source of energy implantable in the patient for supplyingenergy for the operation of the restriction device, wherein the switchis operated by the energy supplied by the energy transmission device toswitch from an off mode, in which the source of energy is not in use, toan on mode, in which the source of energy supplies energy for theoperation of the restriction device.
 142. An apparatus according toclaim 140, further comprising a source of energy implantable in thepatient for supplying energy for the operation of the restrictiondevice, and a remote control for controlling the supply of energy of theimplantable source of energy, wherein the switch is operated by theenergy supplied by the energy transmission device to switch from an offmode, in which the remote control is prevented from controlling thesource of energy and the source of energy is not in use, to a standbymode, in which the remote control is permitted to control the source ofenergy to supply energy for the operation of the restriction device.143. An apparatus according to claim 140, further comprising a source ofenergy implantable in the patient for supplying energy for the operationof the restriction device, wherein the switch is operated by the energysupplied by the energy transforming device to switch from an off mode,in which the source of energy is not in use, to an on mode, in which thesource of energy supplies energy for the operation of the restrictiondevice.
 144. An apparatus according to claim 140, further comprising asource of energy implantable in the patient for supplying energy for theoperation of the restriction device, and a remote control forcontrolling the supply of energy of the implantable source of energy,wherein the switch is operated by the energy supplied by the energytransforming device to switch from an off mode, in which the remotecontrol is prevented from controlling the source of energy and thesource of energy is not in use, to a standby mode, in which the remotecontrol is permitted to control the source of energy to supply energyfor the operation of the restriction device.
 145. An apparatus accordingto claim 1, wherein the prosthesis is operable to perform a reversiblefunction.
 146. An apparatus according to claim 66, further comprising areversing device implantable in the patient for reversing the functionperformed by the prosthesis.
 147. An apparatus according to claim 146,wherein the control device controls the reversing device to reverse thefunction performed by the prosthesis.
 148. An apparatus according toclaim 146, wherein the reversing device comprises hydraulic meansincluding a valve for shifting the flow direction of a flowing fluid inthe hydraulic means.
 149. An apparatus according to claim 146, whereinthe reversing device comprises a mechanical reversing device.
 150. Anapparatus according to claim 146, wherein the reversing device comprisesa switch.
 151. An apparatus according to claim 150, wherein the switchof the reversing device is operable by the released energy.
 152. Anapparatus according to claim 151, wherein the control device controlsthe operation of the switch of the reversing device by shifting polarityof the released energy supplied to the switch.
 153. An apparatusaccording to claim 146, wherein the operation device comprises a motor,and the reversing device reverses the motor.
 154. An apparatus accordingto claim 1, wherein the restriction device is embedded in a soft orgel-like material.
 155. An apparatus according to claim 154, wherein therestriction device is embedded in a silicone material having hardnessless than 20 Shore.
 156. An apparatus according to claim 86, wherein theenergy transforming means or device is designed to be implantedsubcutaneously or in the abdomen, thorax or cephalic region of thepatient.
 157. An apparatus according to claim 124, wherein therestriction device is adapted to release the corpora cavernosa or cruraor the prolongations thereof in response to the sensor sensingejaculation.
 158. An apparatus according to claim 1, wherein therestriction device further comprises two restriction members adapted torestrict the respective corpora cavernosa or crura or the prolongationsthereof.
 159. An apparatus according to claim 1, wherein the restrictiondevice further is adapted to restrict at least one of the penile exitveins.
 160. An apparatus according to claim 1, wherein the adjustmentdevice is adapted to adjust the restriction device such that therestriction device provides a predetermined contraction of the corporacavernosa or crura or the prolongations thereof that is satisfactory forthe patient.
 161. An apparatus according to claim 1, wherein theadjustment device is adapted to adjust the restriction device in anon-flux magnetic or non-thermal manner or non-viscosity changingmanner.
 162. A method of treating male sexual impotence, comprisingsurgically implanting in the patient's body: at least one adjustablerestriction device engaging the corpora cavernosa or crura or theprolongations thereof of the patient's penile tissue; an adjustmentdevice for adjusting the restriction device to temporarily contract thecorpora cavernosa or crura or the prolongations thereof to restrict theblood flow leaving the penis; powered operation device for operating theadjustment device, and a reservoir containing hydraulic fluid, poweringsaid operation device to operate said adjustment device by distributingfluid from said reservoir, whereby said restriction device is adjustedto temporarily restrict the blood flow leaving the penis to achieveerection.
 163. A surgical method according to claim 162, comprisingimplanting an elongated restriction member of the restriction devicearound the corpora cavernosa or crura or its prolongation.
 164. Asurgical method as recited in claim 162, restriction device in the baseof the patient's penis or its prolongation.
 165. A method according toclaim 162, comprising: surgically implanting in the body of a malepatient suffering from sexual impotence at least two adjustablerestriction devices to affect the blood flow leaving the penis engagingrespective of the corpus cavernosa or crura of the penis or itsprolongation as separate units of the patient's penis, and when desiredto achieve erection, non-manually without touching the skin of thepatient adjusting said powered restriction device to temporarilyrestrict the corpora cavernosa or crura or its prolongation to restrictthe blood flow leaving the penis.
 166. A method for treating male sexualimpotence, according to claim 164 comprising: surgically implanting inthe body of a male patient suffering from sexual impotence severalnon-manually adjusted powered restriction devices engaging respectiveexit veins from the penis.
 167. A method for treating male sexualimpotence, comprising the steps of: placing at least two laparascopicaltrocars in the body of a male patient suffering from sexual impotence,inserting a dissecting tool through the trocars and dissecting an areaof the penis and abdominal or retroperitoneal or pelvic surroundings,placing at least one adjustable restriction device in the dissected areaengaging the penile tissue or the prolongation thereof, further placingin the dissected area: an adjustment device for adjusting therestriction device a powered operation device for operating theadjustment device, and a resevoir containing hydraulic fluid; andpowering said operation device to operate said adjustment device bydistributing fluid from said reservoir, whereby said restriction deviceis adjusted to temporarily restrict the blood flow leaving the penis toachieve erection.
 168. A surgical method as recited in claim 167,further comprising hydraulically adjusting said restriction device. 169.A surgical method as recited in claim 167, wherein the restrictiondevice engages both of the corpus cavernosa or crura of the penis or theprolongations thereof as a single unit.
 170. A surgical method asrecited in claim 167, further comprising implanting a further adjustablerestriction device, wherein the two restriction devices engage the twocorpus cavernosa or crura of the penis or their prolongations,respectively, as separate units.
 171. A surgical method as recited inclaim 167, wherein the restriction device engages one of the exit veinsfrom the penis.
 172. A surgical method as recited in claim 167, furthercomprising implanting several restriction devices engaging respectiveexit veins from the penis.
 173. A surgical method as recited in claim167, further comprising implanting a source of energy in the patient andproviding a control device for controlling the source of energy fromoutside the patient's body to supply energy to the operation device.174. A surgical method as recited in claim 173, further supplying saidsource of energy with wirelessly transmitted energy from outside thepatient's body.